Updated EU Regulatory Requirements for Human Health Assessment of Chemicals

The JRC (Joint research Center) of the EU Commission has published an updated comprehensive review on New Approach Methodologies (NAM) in toxicity testing in March 2021. It is entitled “Current EU regulatory requirements for the assessment of chemicals and cosmetic products: challenges and opportunities for introducing new approach methodologies” (Pistollato et al., Arch. Toxicol on-line 2021 https://doi.org/10.1007/s00204-021-03034-y).

The updated review summarizes current EU regulatory requirements for the human health assessment of chemicals. This summary takes into account the respective requirements and constraints imposed by the EU Cosmetics Products Regulation, which bans animal testing for these products, and the EU REACH (registration, evaluation, and authorization of chemicals) regulation, which imposes information requirements for chemicals manufactured in or imported into the EU.

The review considers the critical endpoints and identifies the main challenges in introducing alternative methods into regulatory testing practice. It complements efforts involved in implementing the Strategic Roadmap for Establishing New Approaches to Evaluate the Safety of Chemicals and Medical Products in the United States with regards to defining testing needs as a prerequisite to implementation of alternatives to animal testing.

This publication is VERY SPECIAL SINCE IT CONTAINS WEB-LINKs to all OECD & EU Test Guidelines for TOX-testing both in vitro and in vivo.

Thanks to Prof. Dr. med. Horst Spielmann (Secretary General of EUSAAT/European Society f. Alternatives to Animal Testing) for providing this information!